NAT-TERIFLUNOMIDE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TERIFLUNOMIDE

Available from:

NATCO PHARMA (CANADA) INC

ATC code:

L04AK02

INN (International Name):

TERIFLUNOMIDE

Dosage:

14MG

Pharmaceutical form:

TABLET

Composition:

TERIFLUNOMIDE 14MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0154970001; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-05-16

Summary of Product characteristics

_NAT-TERIFLUNOMIDE (Teriflunomide Tablets) _
_Page 1 of 43_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
NAT-TERIFLUNOMIDE
Teriflunomide tablets
Tablets, 14 mg, Oral
Immunomodulator Agent
Natco Pharma (Canada) Inc.
2000 Argentia Road, Plaza 1, Suite 200
Mississauga, ON L5N 1P7
Date of Initial Authorization:
June 16, 2020
Date of Revision:
October 27, 2023
Submission Control Number: 278125
_ _
_NAT-TERIFLUNOMIDE (Teriflunomide Tablets) _
_Page 2 of 43_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic
10/2023
7 WARNINGS AND PRECAUTIONS, Respiratory
10/2023
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.1 Pregnant
Women
05/2022
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.3 Pediatrics
10/2023
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
RECENT MAJOR LABEL CHANGES
.........................................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
_1.1_
Pediatrics
..............................................................................................................................4
_1.2_
Geriatrics
..............................................................................................................................4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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5
4
DOSAGE AND ADMINISTRATION
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